There was a relatively “low profile” Trulicity double-dose recall by Eli Lilly & Company back in 2021. Because there may still be thousands of double-dose Trulicity injectors in patients’ homes, we are concerned that this is an ongoing Trulicity drug safety issue. Here are seven reasons why:

1. Some Trulicity autoinjector devices labeled as 0.75 mg/0.5 mL, in fact, contain 1.5 mg/0.5 mL of product. As such, those Trulicity products can be viewed as “defective”.
2. This 2021 Trulicity double-dose recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C.
3. When the FDA issued its Enforcement Report for that Trulicity double-dose recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.
4. It was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
5. While the mislabeled Trulicity autoinjector devices were distributed throughout the United States, it appears that the associated Trulicity recall was only down to the retail level.
6. It apparently took Eli Lilly at least two months, from mid-June 2021 to mid-August 2021 — to realize that this double-dose lot of Trulicity had been shipped to US pharmacies to dispense for use by patients.
7. Even though the FDA designated this 2021 Trulicity double-dose recall as “Class II” — by definition, meaning that use of this product could cause temporary or medically reversible adverse health consequences — that FDA Class II designation also indicates there is a remote possibility of serious harm.

If you or someone you know may have suffered an adverse reaction as a result of using a Trulicity autoinjector device which was labeled as 0.75 mg but, later, it was determined the product contained 1.5 mg of Trulicity (a “double-dose”), we would be interested in hearing more about that event. It is possible that a Trulicity drug injury case could be filed against Eli Lilly, depending on the circumstances. For that purpose, one can submit a Case Evaluation Form to us for review.

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